Duns Number:605151018
Device Description: Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during thehemodialysis procedure.
Catalog Number
5119C
Brand Name
Serim® GUARDIAN™ Blood Leak Test Strips
Version/Model Number
5119C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012115,K012115,K012115,K012115
Product Code
FJD
Product Code Name
Detector, Leak, Blood
Public Device Record Key
e7eed404-9689-42d2-8b91-682f75550c0d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 12, 2017
Package DI Number
M1745119C2
Quantity per Package
2
Contains DI Package
M1745119C
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit